Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Myeloid Leukemia
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- PDC for chronic condition medications
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (Pharmacists Coordinated care Oncology Model [PCOM]).
This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has primary care physician
- •Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
- •Initiating an OAA, either for the first time or a change from previous OAA
- •Diagnosis of at least 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease
- •Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
- •Willing and able to sign informed consent.
Exclusion Criteria
- •Cannot speak English
- •Concurrent diagnosis of type 1 diabetes
- •Concurrent diagnosis of human immunodeficiency virus
Outcomes
Primary Outcomes
PDC for chronic condition medications
Time Frame: Up to 6 months following OAA initiation
PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
Time Frame: Up to 6 months following OAA initiation
PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.
Secondary Outcomes
- Percent of patients with completed Comprehensive Medication Reviews (CMRs)(Day 50 (+/-3) after OAA initiation)
- Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result(Day 22 (+/-3) after OAA initiation)
- Percent of CMRs where note was routed to oncology pharmacist(Up to day 43 (+/-3) after OAA initiation)
- Percent of patients with two completed Patient Reported Outcome Measures (PROMs)(Up to day 42 (+/-3) after OAA initiation)
- Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM(Up to day 44 (+/-3) after OAA initiation)
- Percent of CMR notes that oncology pharmacist reviewed(Up to day 44 (+/-3) after OAA initiation)